A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

doxycycline

About this trial

This is an interventional treatment trial for Rosacea focused on measuring rosacea, acne rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria: Healthy patients with rosacea Males and females ≥18 years of age 10 to 40 papules and pustules and ≤2 nodules Score of 2 to 4 on the IGA Presence of telangiectasia Moderate to severe erythema Main Exclusion Criteria: Use of topical acne treatments or topical or systemic antibiotics Use of systemic retinoids within 90 days of baseline Use of an investigational drug within 90 days of baseline Pregnant or nursing women Women of childbearing potential not using an adequate form of contraception Change in method of contraception within 4 months of baseline Known hypersensitivity to tetracyclines Surgeries that bypass or exclude the duodenum or achlorhydria

Sites / Locations

Outcomes

Primary Outcome Measures

Change in total inflammatory lesion count

Secondary Outcome Measures

Change from baseline in erythema scale scores

change from baseline in the investigator's global assessment (IGA) score

proportion of patients being clear or near-clear at endpoint

Full Information

NCT ID

NCT00126399

First Posted

August 2, 2005

Last Updated

August 18, 2005

Sponsor

CollaGenex Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00126399

Brief Title

A Clinical Trial to Determine the Effects of 40 Mg Doxycycline Versus a Placebo Control for the Treatment of Rosacea

Study Type

Interventional

2. Study Status

Record Verification Date

August 2005

Overall Recruitment Status

Completed

Study Start Date

June 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

CollaGenex Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

The objective of this study is to evaluate the safety and efficacy of 40 mg doxycycline controlled-release capsules administered once daily for the treatment of rosacea compared with a placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rosacea

Keywords

rosacea, acne rosacea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

528 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

doxycycline

Primary Outcome Measure Information:

Title

Change in total inflammatory lesion count

Secondary Outcome Measure Information:

Title

Change from baseline in erythema scale scores

Title

change from baseline in the investigator's global assessment (IGA) score

Title

proportion of patients being clear or near-clear at endpoint

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Main Inclusion Criteria: Healthy patients with rosacea Males and females ≥18 years of age 10 to 40 papules and pustules and ≤2 nodules Score of 2 to 4 on the IGA Presence of telangiectasia Moderate to severe erythema Main Exclusion Criteria: Use of topical acne treatments or topical or systemic antibiotics Use of systemic retinoids within 90 days of baseline Use of an investigational drug within 90 days of baseline Pregnant or nursing women Women of childbearing potential not using an adequate form of contraception Change in method of contraception within 4 months of baseline Known hypersensitivity to tetracyclines Surgeries that bypass or exclude the duodenum or achlorhydria

Rosacea

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial